This invention concerns medicine and biology, in particular, it concerns physiotherapy and photobiology and it deals with the therapeutic influence of light on various human being""s organs, micro-organisms and plants in combination with other kinds of energy, including magnetic field, electrostimulation, mechanical therapy, vacuum-therapy, etc.
A device for light-therapeutic influence on different human being""s areas is known; it consists of the sources of optical radiation, for example, such as lasers or light diodes coupled with a power supply unit and a timer [Illarionov V.E. Fundamentals of laser therapy, Moscow, Respect, 1992, pp. 26, 31, 71-80]. Sources of radiation are placed separately or installed into anglepoised heads or connected with light fibers, through which the radiation is directed onto the bioobject. The disadvantage of such devices is the difficulty in creating the uniform light exposure over extensive pathological zones on the human being""s body, especially when these zones have complex spatial geometry.
The closest device, in technical terms, is a combined therapeutic device, which consists of several narrow-band sources in form of light diodes with the radiation wavelengths varying in the spectrum range from 0.25 xcexcm to 2 xcexcm [1]. The sources of radiation can operate either in a continuous mode or in a pulse one with a wide range of frequencies and pulse profiles. The sources of radiation are usually placed at the butt-end parts of anglepoised hands, which can be fixed against the shell of a power supply unit with the help of special holders.
The drawbacks of these device are the impossibility to irradiate extensive pathological zones when they are located, for instance, on different sides of the bioobject, which is typical, in particular, for burns, oedemas or dermatological pathologies that involve all sides of a limb; difficulty in selective irradiation of a surface with complex geometry in accordance with the given pattern of irradiation, for example, elbow and knee bents, the upper side of the head, areas of the alimentary tract, sex organs, etc. with the simultaneous exception of neighbouring areas from the process of irradiation; the impossibility of establishing a required distance between the sources of radiation and bioobject along the whole pathological zone, particularly, to avoid the danger of potential touching a wounded or burnt surface by the sources at involuntary movements of the patient; excessive locality and low dose of influence with respect to the whole pathology in photodynamic therapy of voluminous tumours or in the above-skin irradiation of blood.
In order to exclude the shortcomings mentioned, i.e., to increase the effectiveness of light therapy when treating extensive pathological zones with a complex geometry, the device is equipped with the sources of radiation with a singular spectrum range or various spectrum ranges which are connected with a control unit, a power supply unit and supplementary physiotherapeutic modules (ultrasonic, vacuum, magnetic, electric and other kinds of therapy) placed outside, in particular, on a substrate whose shape is similar to the shape of the spatially extensive pathological zone. Indicatrixes of radiation for each source and their position in space around the bioobject are oriented so as to provide the required distribution, for example, a uniform light exposure within the area of interest. Wavelengths of the sources are chosen on the basis of concurring the absorption wavelengths of biomolecules of both exogenous and endogenous origins.
The sources of radiation (emitters) in the case of a relatively smooth change of the surface relief are placed uniformly on the substrate. Their number N, the distance between them d and the power for each of them P can approximately be determined from the system of interconnected expressions:                                           P            ≈                                          I                ⁢                                  xe2x80x83                                ⁢                π                ⁢                                  xe2x80x83                                ⁢                                  R                  2                                            k                                ;                ⁢                  xe2x80x83                                    (        1        )                                          d          ≤                                    2              ⁢              R                        k                          ;                            (        2        )                                          N          ≥                                    I              ⁢                              xe2x80x83                            ⁢              S                                      P              ⁢                              xe2x80x83                            ⁢              τ                                      ,                            (        3        )            
where Ixe2x80x94the intensity of radiation on the bioobject""s surface with the pathological zone square S; Rxe2x80x94the mean radius of the light spot on the bioobject produced by a single source of radiation that is determined through the equation R=hxc2x7tg xcex1, where hxe2x80x94the average distance between the surface of the substrate and the bioobject; xcex1xe2x80x94the half-angle of divergence of radiation from the source; xcfx84xe2x80x94losses of radiation in optical systems (0xe2x89xa6xcfx84xe2x89xa61); kxe2x80x94the ratio that takes into consideration the degree of overlapping the light beams on the bioobject""s surface (1kxe2x89xa6N).
In order to introduce the average distance h between the object and the source of radiation and to avoid their touching, additional stops are placed between the source of radiation and bioobject. For instance, these stops can be made in form of spring elements connected with the substrate at one side and with flexible rings, which grasp the bioobject (for example, a limb), at the other side. To get the best usage of the radiation scattered or reflected from the bioobject, the surface of the substrate between the sources of radiation is made mirror-like. In order to fix the substrate against the bioobject, a holder in form of, for instance, adhesive tape is introduced. A commutation unit, coupled with the control unit, and other physiotherapeutic modules as well as the biological sensors of feedback connected with the commutation unit are introduced additionally, which provides the switching of the sources with different spectrum ranges and supplementary physiotherapeutic modules in accordance with a program given, for example, it can provide their separate or simultaneous operation.
Apart from that, the substrate can be furnished with side flanges, which have elastic edges bordering on the bioobject""s surface, to provide the air-tightness of the space over the pathological area, with additional modules connected with the corresponding control units being installed into the substrate to regulate the temperature, pressure and gas composition over the pathological area as well as to bring various medicinal and other substances, for instance, magnetic fluids and sprays.
Moreover, a hood transparent for the radiation is introduced between the surfaces of the substrate and bioobject, with its edges adjoining the bioobject""s surface, into which the physiotherapeutic modules enumerated above are installed.
Furthermore, a flexible elastic strip grasping the pathological area tightly is introduced between the surfaces of the substrate and bioobject; the strip is suffused with a medicinal compound and is transparent for the optical-range radiation employed.
The light sources can be made in form of distant ends of light-guides connected with the corresponding sources of radiation, in particular, with lasers installed into the substrate, with the semi-mirror-like diffusive strip following the bioobject""s shape and being placed between the surfaces of the substrate and bioobject. A required distribution of radiation, including a uniform one, over a large surface can also be achieved with the help of the system of splitting mirrors.
The control and commutation units together with the autonomous power supply unit can be placed immediately on the substrate, with the power supply unit being made either as a one-time operation unit using the packet of miniature batteries or as a re-usable operation unit at the expense of using re-chargeable batteries. Remote power supply is realised by inductive coil coupled with the sources of radiation and additional physiotherapeutic modules, in particular, with electrodes for an electrostimulator, and an external source of pulse electromagnetic field with the following parameters: the pulse width is about 10xe2x88x926-10xe2x88x922sec, the tension of the magnetic field is 10xe2x88x923-10 Tesla, the frequency of repetition is 1-103 Hz.
The source of optical radiation can also be made in form of a concavity shaped in the substrate having optical windows filled with chemical substances, in which the radiation is formed in the course of chemical reactions between separate substances or as a result of non-linear interactions of the radiation from the primary sources of radiation with the substances by means of various physical effects, including the doubling of harmonics, combinational scattering and fluorescence.
In all the modifications of photomatrix systems enumerated above the substrate can be made of rigid materials such as metal, plastic, polymerised substance, glass, ceramics, or other materials. The sources of radiation can be fixed mechanically or with the help of glue. At relatively small caviture of the surface, the substrate can be made as a monolithic integrated chip with hybrid microcristalline light diodes or lasers soldered-in. Given the high density of placing the light diodes and high feeding electric currents, it is necessary to introduce a cooling system on both the working surface of the substrate turned to the bioobject and its external side, for example, with help of micro-fans.
If the spatial geometry is very complex and causes certain difficulties in creating continuous rigid matrix, the latter should be made of separate segments with a flat or nearly flat working surface attached to each other with a rigid or flexible bond. The simplest form of these segments is rectangular and they can be manufactured in form of integrated chips, grasping the pathologic area, for example a limb, uniformly on all sides. The size of separate segments and their shape should trace the relief of the surface.
Using compact and light sources of radiation, for instance, light diodes, it is likely to fix them to a soft flexible substrate such as a piece of medical fabric, gauze, adhesive tape which at wrapping or grasping adopts the shape of the pathological area. A protective transparent substrate or film can be introduced near the sources of radiation to isolate them from the bioobject, which is indispensable for disinfection. Each source of radiation can have its independent optics, for example, positive or negative lenses or diffusive coating, in particular, on the surface of light diodes, which provides the re-distribution of energy of radiation within a wide angle: up to 180xc2x0. It is also workable to utilise a common diffusive screen for all the sources.
In the first place in this invention it is suggested to use compact semiconductor hybrid lasers and light diodes emitting within a wide range of spectrum and possessing a broad range of technical parameters. Nevertheless, one can employ compact discharge and luminescent lamps as well as sources operating in the radio-wave range. It is promising to utilise photomatrix systems in photodynamic therapy of both malignant and non-malignant diseases. In order to irradiate extensive oncological tumours, external matrixes with lasers or light diodes can be applied. Modern semiconductor technology allows one to reach the flux from light diodes up to 200 mW/cm2 over the square up to 1,000-2,000 cm2 at the wavelength of absorption for widely known photosensitizers in the range from 0.63 to 0.8 xcexcm. It is also suggested to densely place light diodes within cylindrical and spherical probes and catheters to use them jointly with endoscopic techniques during irradiation of tumours in the alimentary tract or when puncturing tissues.
Among non-malignant applications of photodynamic therapy, it is suggested to utilise photomatrixes to treat various dermatologic diseases and infectious processes largely due to the bactericidal action of photosensitizers through generating active radicals and singlet oxygen. Since any photosensitizer is able to kill only determine kinds of bacteria, its universality can be increased by means of using photomatrixes with different wavelengths so as to irradiate photosensitizer mixtures with different absorption bands. In order to provide the additional intermingling of the photosensitizer in the solution over the pathological zone, it is suggested to employ an ultrasonic device whose working tip is placed into corresponding solution. Radicals will be formed in the solution in force of the cavitation effect, i.e., one can realise the combined mode of photosonodynamic therapy.
In addition, it is suggested to utilise high-power infrared light diodes (up to 0.5-5 W) that provide the short-term heating of pathologic zones up to 40-41xc2x0 C. to enhance blood microcirculation, which is healthful at treating arthritis. The heating of bioobject""s surface, which is in contact with the photomatrix, can be actualised through heating the photomatrix itself.
Compactness, lightness and flexibility of the photomatrixes allow combining them with other therapeutic techniques, in particular, with apparatuses for magnetic therapy and electrostimulation. This can be reached by means of installing photomatrixes into devices, which generate both continuous and pulse magnetic fields, for instance, solenoids with flat and cylindrical geometry. It is also suggested that photomatrixes be combined with electrostimulators through docking electrodes at the edges of photomatrixes or in form of multi-electrode systems, for example, small metal needles placed between the sources of radiation.
The photomatrixes"" shape can be chosen arbitrarily but it should be maximally adapted to the geometry of the pathological area. Particularly, the following shapes have been suggested: in form of a facial mask, glove, gadgets that follow the internal shape of the nose, ear, mouth and other inner concavities; built into transurethral, transrectal catheters, gynaecological probes. Matrixes with the shapes that permit one to uniformly wrap the areas of adipose tissue accumulation, for instance, on the stomach, neck, thighs are also suggested to transform, for example by means of using the photosensitizers, the adipose tissue into soluble compounds that can be eliminated out of the organism easily. The photomatrixes suggested are easy to put into human being""s clothes, bed constant wear garment, subjects of household activities (watches, spectacles, bracelets, etc.) to irradiate the body according to a special program so as to regulate his or her mood, to influence the biological rhythms, immune system, blood. It is feasible to locate photomatrixes on the outside part of low-pressure chambers, incubators for new-borns, transparent chambers to conduct photobiological investigations of photosynthesis and agricultural experiments. The usage of infrared sources in so-called windows of transparency for biological tissues allows providing the uniform exposure of some internal organs, particularly, the lungs to treat tuberculosis, the brain to accelerate the production of a number of biological molecules such as serotonin.
Thanks to the features marked above, the device declared is the first to provide the effective treatment of spatially extensive pathological zones, including oedemas, varicose veins, dermatologic and oncologic diseases, extensive infectious and inflammatory processes (ulcers, pus wounds, etc.), it also provides the efficient light-therapy of blood, therapy of yellow jaundice, etc.
The most significant difference is that the shape of the substrate with the sources of radiation traces the shape of the pathological zone irradiated with any configuration and square, which have never previously been achieved. Using this device, it is practicable to uniformly irradiate the whole face, head (cosmetology, dermatology), sex organs (treatment of prostatitis, impotence), elbow and knee joints, woman""s breast, limbs including feet and hand fingers, as well as the whole human being""s body.
Any sources of radiation can be taken but the most promising ones according to the overall dimensions and economic reasons, as it has been mentioned above, are the semiconductor lasers of a small size and super-miniature light diodes emitting radiation in a spectrum range of 0.25 xcexcm up to 2-3 xcexcm. Numerous fundamental investigations have shown that biological action of laser and light diode sources of radiation with a relatively narrow emitting band up to 15-20 nm is practically identical, with the absorption width of basic biostructure components being quite wide: up to 40-60 nm, which allows the utilisation of non-laser sources of radiation in medicine. In the capacity of the sources of radiation with the required spectrum range, the radiation of chemeluminescence caused by the chemical reactions of a number of substances can also be employed. When one uses relatively bulky and cumbersome lasers, it is feasible to employ the standard delivery of radiation towards the bioobject through light-guides. However, in order to irradiate extensive areas, it is requisite to utilise a multi-fibre system, in which separate fibres are gathered in one tight plait and at the end of the plait the fibres are attached to separate areas of the substrate, with a diffusive semi-mirror-like (semi-transparent) strip being introduced to produce a more uniform exposure, which provides the required effect by dint of re-reflecting and scattering the radiation within this strip. The minimum number of sources of radiation is determined in accordance with the expressions (1)-(3) to satisfy the required degree of overlapping the light zones from each source of radiation on the bioobject""s surface. To make use of the radiation with better efficiency, in particular, to use the radiation reflected from the bioobject, the working surface of the substrate should be made mirror-like. The beneficial advantage of this invention is the presence of stops, which establish the mean distance between the surfaces of the substrate and bioobject, and a holder that fixes the substrate on the patient""s body. In this case there is no necessity for the patient to be immovable during the therapeutic procedure and there is no possibility for the sources of radiation to accidentally touch ulcers, pus wounds or burns, even if the distance between the surface of the substrate and the bioobject is small and if the spatial geometry is complex.
According to the analysis conducted, different physiotherapeutic techniques supplement each other favourably and in combination they can provide a significant treating response. In this invention, this advantage is provided particularly by means of using both light-therapy and electromagnetic therapy. The sources of continuous or pulse magnetic field are placed on the substrate or near it and influence the bioobject sequentially or synchronically with the light radiation, which is set by the commutation unit. In the device depicted, a feedback channel is worked out operating on the basis of various biosensors (acoustic, rheographic, temperature, etc.) that register the corresponding effects of combined influence on the organism and manage the cure process through the commutation unit.
In this device, due to the creation of the air-tight space over the area of pathology, a unique opportunity exists to change the parameters of local environment, including the temperature, pressure, gas composition, etc. For example, the concentration of oxygen can be reduced through instilling some inert gas to suppress infectious processes. There exists the possibly to periodically or continuously introduce drugs on the top of a wound simultaneously with the irradiation, which permits the realisation of, for instance, a local photodynamic therapy technique to treat either malignant or non-malignant ailments, in the latter case by dint of utilising the accompanying bactericidal effect. The closed air-tight space can be realised with the help of placing a hood transparent for the radiation, in which it is possible to create, for example, air rarefaction, as it has been actualised in vacuum-therapy. One of promising applications of this combined photovacuum therapy is to treat men""s impotence. There is also a module to measure the bioobject""s temperature to realise combined photo-hyperaemia or crio-therapy.
In order to realise combined photodrug therapy besides the forced introducing of drugs into the pathological zone, it is practicable to place a thin strip or gauze suffused with a drug, for instance, with photogem or photosens, immediately on the bioobject""s surface. This is important while treating various oncological and dermatological diseases. This strip, made of thin elastic material, can wrap the pathological area tightly, for example a limb, which allows one to realise a unique combined method of photomechanical therapy of oedemas. In the case of employing super-miniature light diodes with a relatively low electrical power consumption, it is feasible to use a compact power supply unit placed right on the substrate. Thanks to this, it is possible to realise a unique method of treating, for instance, varicose veins by dint of compact and light device attached immediately on the patient""s leg that will make it possible for the patient to move freely, for example, in the out-patient or home conditions under the doctor""s supervision.
Thus, in general, a quite universal combined phototherapeutic device is suggested, which alloys many unique peculiarities and this permits increasing the effectiveness of light-treatment with respect to a number of severe diseases, which has never previously been possible to realise.